Sr Manager Global Unique Device Identifier (UDI) Program Management

Brighter Signals; Raynham (MA); On-site; USD 122,000 - 213,000; Full time

Job summary

The Sr Manager, UDI PMO leads strategic planning, governance, and execution of the UDI program within Strategic Governance and Insights, ensuring global regulatory compliance and data integrity. Role offers high visibility and cross-functional leadership across DePuy Synthes.

You will influence patient safety and regulatory outcomes across the portfolio, driving scalable UDI processes and standards globally.

Qualifications

• Bachelor’s degree in Engineering, IS, Life Sciences, or related field required.
• 8–10 years in Quality, Regulatory, Technology, or Program Management in a regulated industry (medical device preferred).
• Experience leading global, cross-functional programs with PMO experience.
• Strong knowledge of UDI regulations and quality system requirements.

Responsibilities

• Lead UDI PMO with governance, roadmaps, milestones, and metrics.
• Oversee UDI-related technology initiatives across ERP, labeling, master data, and regulatory submission systems.
• Partner with Quality, Regulatory Affairs, Supply Chain, IT, and Commercial teams to drive end-to-end UDI compliance and execution.
• Ensure inspection readiness with documentation, risk management, change control, and audit support processes.
• Lead and develop a PMO/UDI team, fostering accountability and quality culture.
• Monitor regulatory changes related to UDI and implement timely updates.
• Manage program risks, dependencies, and resource planning for on-time delivery.
• Drive process improvement using PMO principles and quality systems.

Skills

UDI knowledge

Regulatory leadership

Cross-functional leadership

Quality system

PMO leadership

Education

Bachelor's degree in Engineering / Information Systems / Life Sciences

Master's degree preferred

Tools

ERP systems

Regulatory systems

Job description

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals. Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes.

We are searching for the best talent for Sr Manager Global Unique Device Identifier (UDI) Program Management, located in one of the following locations:

• Raynham, MA
• Bridgewater, NJ
• Cork, Ireland
• Dublin, Ireland
• Palm Beach Gardens, FL
• Warsaw, IN

Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):

United States - Requisition Number: R-102789

Ireland – Requisition Number: R-107632

Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

About MedTech

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

Learn more at https://www.jnj.com/medtech

Purpose

The Sr. Manager, UDI PMO leads the strategic planning, governance, and execution of the Unique Device Identification (UDI) program within Strategic Governance and Insights, This role is critical to ensuring global regulatory compliance, data integrity, and sustained inspection readiness while enabling efficient, scalable UDI processes across systems and business partners. The role offers high visibility, cross‑functional leadership, and the opportunity to directly impact patient safety and regulatory outcomes across the DePuy Synthes portfolio.

You Will Be Responsible For

• Lead the UDI Program Management Office (PMO), establishing governance, roadmaps, milestones, and performance metrics aligned to global regulatory requirements (FDA, EU MDR, and other health authorities).
• Provide strategic oversight for UDI‑related technology initiatives, ensuring integration across ERP, labeling, master data, and regulatory submission systems.
• Partner with Quality, Regulatory Affairs, Supply Chain, IT, and Commercial teams to drive end‑to‑end UDI compliance and execution.
• Ensure inspection readiness by maintaining robust documentation, risk management, change control, and audit support processes.
• Lead and develop a team of PMO and UDI professionals, fostering accountability, continuous improvement, and strong quality culture.
• Monitor global regulatory changes related to UDI and assess business impact, driving timely implementation of required updates.
• Manage program risks, dependencies, and resource planning to ensure on‑time, compliant delivery of UDI initiatives.
• Drive process optimization and standardization using PMO best practices and quality system principles.

Qualifications / Requirements

• Bachelor’s degree in Engineering, Information Systems, Life Sciences, Quality, or a related field is required. Master’s degree (MS, MBA) in a relevant discipline is preferred.
• 8–10 years of progressive experience in Quality, Regulatory, Technology, or Program Management within a regulated industry (medical device preferred).
• Demonstrated leadership of complex, cross‑functional programs with global scope.
• Strong knowledge of UDI regulations and quality system requirements.
• Experience working with enterprise systems (ERP, labeling, master data, regulatory systems).
• Proven ability to lead teams, influence stakeholders, and drive execution in a matrixed environment.

Preferred

• Experience supporting regulatory inspections and health authority audits related to UDI or data integrity.
• PMO leadership experience within Technology Quality and Regulatory organizations.
• Familiarity with EU MDR, FDA UDI, and global device registration frameworks.
• Experience driving process improvement initiatives (Lean, Six Sigma).
• Background in medical device manufacturing or orthopedic products.
• Excellent communication, risk management, and decision‑making skills.
• Certifications: PMP, PgMP, Lean Six Sigma, or equivalent.

Other

• Proficiency (oral & written) in the English language is required.
• Up to 25% domestic and occasional international travel may be required.
• Candidates must already have authorization to work in the country of employment. Immigration sponsorship and relocation support are not available for this position.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers. Internal employees contact AskGS to be directed to your accommodation resource.

Preferred Skills

Agile Decision Making, Agility Jumps, Analytics Insights, Business Alignment, Continuous Improvement, Cross‑Functional Collaboration, Leadership, Organizational Project Management, Organizing, Program Management, Project Management Methodology (PMM), Project Management Office (PMO), Project Management Tools, Project Reporting, Statement of Work (SOW), Technical Credibility

The anticipated base pay range for this position is :

$122,000.00 - $212,750.00

Additional Description For Pay Transparency

Subject